Kit for the Preparation of Technetium Tc99m Medronate recalled over sterility concerns

Recall date

June 6, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Pharmalucence, Inc. recalls Kit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, packaged in a) 5-count box (NDC 45567-0040-1…

Recall number

D-1040-2018

FDA classification

Class II

Brand / firm

Pharmalucence, Inc.

Sold / distributed

Nationwide

Why it was recalled

Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Kit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, packaged in a) 5-count box (NDC 45567-0040-1), b) 30-count box, NDC 45567-0040-2 , Rx only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821.